BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE TRANSFER STRAW

    MDR report key: 12962103 · Received December 8, 2021

    Report

    Report Number
    1917413-2021-01046
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    October 28, 2021
    Report Date
    February 15, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JSM
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1068690. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: 2021-03-09. MEDICAL DEVICE LOT #: 1068691. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: 2021-03-09. MEDICAL DEVICE LOT #: 1153442. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: 2021-06-02. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 2/18/2022. H.6. INVESTIGATION: BD RECEIVED FIVE (5) SAMPLES FROM EACH BATCH # (1068690, 1068691, 1153442) AND ONE (1) PHOTO FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR HOLDER AND STRAW/NEEDLE ASSEMBLY SEPARATION WAS OBSERVED. THE PHOTO SHOWS THE HOLDER HAS BECOME SEPARATED FROM THE STRAW AND NEEDLE ASSEMBLY. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR HOLDER AND STRAW/NEEDLE ASSEMBLY SEPARATION WITH THE INCIDENT LOT WAS NOT OBSERVED. WHEN THE STRAW AND HOLDER WERE MANUALLY PULLED APART, NO SEPARATION OF THE NEEDLE/STRAW ASSEMBLY FROM THE HOLDER WAS IDENTIFIED. INSPECTIONS WERE COMPLETED DURING THE PRODUCTION RUN WITH NO ISSUES BEING IDENTIFIED. A PROGRAMMING CHANGE WAS COMPLETED ON (B)(6) 2021 THAT WOULD STOP THE MACHINE IF ADHESIVE BOND WAS NOT APPLIED TO THE PRODUCT. THE REPORTED BATCH # 1068690, 1068691 AND 1153442 WERE MANUFACTURED BEFORE THE PROGRAMMING CHANGE WAS IMPLEMENTED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NOTIFICATIONS. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF HOLDER AND STRAW/NEEDLE ASSEMBLY SEPARATION BASED ON THE PROVIDED PHOTO; HOWEVER, THERE WERE NO ISSUES IDENTIFIED WITH THE RETURNED SAMPLES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT ONE (1) PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR HOLDER AND STRAW/NEEDLE ASSEMBLY SEPARATION WAS OBSERVED. THE PHOTO SHOWS THE HOLDER HAS BECOME SEPARATED FROM THE STRAW AND NEEDLE ASSEMBLY.INSPECTIONS WERE COMPLETED DURING THE PRODUCTION RUN WITH NO ISSUES BEING IDENTIFIED. A PROGRAMMING CHANGE WAS COMPLETED ON 10/22/2021 THAT WOULD STOP THE MACHINE IF ADHESIVE BOND WAS NOT APPLIED TO THE PRODUCT. THE REPORTED BATCH # 1068690, 1068691 AND 1153442 WERE MANUFACTURED BEFORE THE PROGRAMMING CHANGE WAS IMPLEMENTED.BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NOTIFICATIONS. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF HOLDER AND STRAW/NEEDLE ASSEMBLY SEPARATION BASED ON THE PROVIDED PHOTO. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE TRANSFER STRAW THE NEEDLE INSIDE THE TRANSFER STRAW WAS DISLODGED AND LOOSE FROM THE STRAW. THIS EVENT OCCURRED 100 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WAS EXPOSURE OF THE NEEDLE WHICH CAME APART FROM THE HOLDER. ADDITIONAL INFORMATION RECEIVED (B)(6) 2021: "NO MEMBERS OF THE STAFF HAVE BEEN INJURED."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE TRANSFER STRAW THE NEEDLE INSIDE THE TRANSFER STRAW WAS DISLODGED AND LOOSE FROM THE STRAW. THIS EVENT OCCURRED 100 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WAS EXPOSURE OF THE NEEDLE WHICH CAME APART FROM THE HOLDER. ADDITIONAL INFORMATION RECEIVED 2021-11-12: "NO MEMBERS OF THE STAFF HAVE BEEN INJURED."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE TRANSFER STRAW THE NEEDLE INSIDE THE TRANSFER STRAW WAS DISLODGED AND LOOSE FROM THE STRAW. THIS EVENT OCCURRED 100 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WAS EXPOSURE OF THE NEEDLE WHICH CAME APART FROM THE HOLDER. ADDITIONAL INFORMATION RECEIVED 2021-11-12: "NO MEMBERS OF THE STAFF HAVE BEEN INJURED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862462 BD VACUTAINER® URINE TRANSFER STRAW TRANSPORT CULTURE MEDIUM JSM BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown